rowasa

Generic: mesalamine

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name rowasa
Generic Name mesalamine
Labeler viatris specialty llc
Dosage Form SUSPENSION
Routes
RECTAL
Active Ingredients

mesalamine 4 g/60mL

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 0037-0066
Product ID 0037-0066_aaf669c5-34ff-40cd-a33f-b13c7ec7e292
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019618
Listing Expiration 2026-12-31
Marketing Start 2016-03-24

Pharmacologic Class

Established (EPC)
aminosalicylate [epc]
Chemical Structure
aminosalicylic acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00370066
Hyphenated Format 0037-0066

Supplemental Identifiers

RxCUI
206798 238151
UNII
4Q81I59GXC
NUI
N0000175781 M0000971

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name rowasa (source: ndc)
Generic Name mesalamine (source: ndc)
Application Number NDA019618 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 4 g/60mL
source: ndc
Packaging
  • 28 BOTTLE, DISPENSING in 1 CARTON (0037-0066-03) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)
  • 7 BOTTLE, DISPENSING in 1 CARTON (0037-0066-05) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)
source: ndc

Packages (2)

0037-0066-03 28 BOTTLE, DISPENSING in 1 CARTON (0037-0066-03) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06) 0037-0066-05 7 BOTTLE, DISPENSING in 1 CARTON (0037-0066-05) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)

Ingredients (1)

mesalamine (4 g/60mL)

Linked Drug Pages (1)

Rowasa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "aaf669c5-34ff-40cd-a33f-b13c7ec7e292", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["206798", "238151"], "spl_set_id": ["e505ab99-1943-4216-a178-4d5dbe64e3b2"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 BOTTLE, DISPENSING in 1 CARTON (0037-0066-03)  / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)", "package_ndc": "0037-0066-03", "marketing_start_date": "20160324"}, {"sample": false, "description": "7 BOTTLE, DISPENSING in 1 CARTON (0037-0066-05)  / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)", "package_ndc": "0037-0066-05", "marketing_start_date": "20160324"}], "brand_name": "Rowasa", "product_id": "0037-0066_aaf669c5-34ff-40cd-a33f-b13c7ec7e292", "dosage_form": "SUSPENSION", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "0037-0066", "generic_name": "mesalamine", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rowasa", "active_ingredients": [{"name": "MESALAMINE", "strength": "4 g/60mL"}], "application_number": "NDA019618", "marketing_category": "NDA", "marketing_start_date": "20160324", "listing_expiration_date": "20261231"}